Physiologic Effects of Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) Versus Noninvasive… (NCT01928238) | Clinical Trial Compass
CompletedNot Applicable
Physiologic Effects of Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) Versus Noninvasive Pressure Support Ventilation in Patients at Risk for Respiratory Distress Needed Preventive Used of Noninvasive Ventilation After Extubation.
France13 participantsStarted 2012-08
Plain-language summary
The purpose of this study is to compare inspiratory effort, comfort, gas exchange and patient ventilator synchrony during non-invasive neurally adjusted ventilatory assist or pneumatically triggered and cycled-off noninvasive pressure support ventilation (NPSV), in patient at risk of respiratory distress after extubation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
inclusion criteria:
* Patients intubated for 48 h or more
* Patients who tolerated a 120-min spontaneous breathing trial after recovery from their acute disease with no signs of respiratory failure
* Patients at high risk for respiratory after extubation were enrolled if they had at least two of the following risk factors for respiratory failure after extubation:
* age older than 65 years
* Chronic obstructive pulmonary disease,
* heart failure as the cause for intubation
* An Acute Physiology and Chronic Health Evaluation (APACHE)-II score greater than 12 on the day of extubation.
exclusion criteria:
* Age younger than 18 years
* Head trauma or surgery
* Recent gastric or oesophageal surgery
* Active upper gastrointestinal bleeding
* Excessive amount of respiratory secretions
* Poor cooperation
* Decision to limit life-supporting treatments in the ICU
* Tracheostomy or other upper airway disorders
* Lack of collaboration
* Do not resuscitate order or any decision to limit therapeutic effort in the ICU.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared two types of breathing support — NAVA and pressure support ventilation — after a breathing tube is removed; can you explain what the key differences are between these two approaches and which one you would recommend for my situation?
2Since this study focused on measuring how hard the breathing muscles have to work during each type of noninvasive ventilation, what does that mean for my recovery — and is reducing that muscle effort an important goal in my specific case?
3This trial enrolled patients considered at risk for breathing problems after extubation — do I fall into that higher-risk category, and how would that affect which type of breathing support you'd choose for me?
4The trial is now completed, so are there published results available, and if so, did one method show a meaningful advantage in reducing breathing muscle strain that might influence my care plan?
5Since standard noninvasive pressure support ventilation already exists as a common treatment, is there a reason to consider the NAVA approach over the more established method, or would you start with the standard option first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.